Statistical Programmer II

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver statistical programming assistance for clinical trials.

• Create and validate SDTM datasets, analysis datasets, tables, listings, and figures through statistical analyses.

• Execute designated statistical programming for clinical trial analysis and reporting.

• Operate under the guidance of senior statistical programmers.

• Review Statistical Analysis Plans prior to programming analyses.

• Utilize appropriate statistical techniques for data analysis.

• Aid in the design and development of SAS macros and other tools.

• Produce tables, listings, and figures in accordance with protocols, Statistical Analysis Plans, and approved client requests.

• Engage in validation and quality control activities for statistical programs.

• Support with SDTM aCRF and specifications, ensuring programming and validation of CDISC SDTM and ADaM datasets.

• Create define.xml and tables of contents for regulatory submissions.

• Collaborate with Clinical Operations, Project Management, and Data Management to facilitate successful project execution and enhance client satisfaction.

• Implement data-cleaning checks through programming.

• Complete assigned tasks within allocated hours.

• Utilize project infrastructure for SAS datasets and SAS code.

• Adhere to Ora standard procedures, sponsor requirements, quality systems, data integrity processes, business ethics, and regulatory standards.

⛳️ Requirements

• A Bachelor's degree in computer science, statistics, or a related scientific discipline, along with two (2) to four (4) years of pertinent professional experience; or an equivalent blend of relevant education and/or experience.

• Strong analytical capabilities with the ability to process scientific and medical data.

• Proficiency in SAS programming is essential.

• In-depth knowledge of SAS/Base.

• Familiarity with SAS/Stat and SAS Macros.

• Basic understanding of SAS/Graph.

• Experience in manipulating and analyzing SAS data.

• Capability to independently recognize data issues, articulate problems clearly, and implement efficient and effective solutions.

• Understanding of clinical trial design and analysis processes.

• Basic knowledge of FDA/CFR and ICH/GCP regulatory standards.

• BASE SAS and Advanced SAS Certification or equivalent experience is preferred.

• Ability to set objectives, establish structure, and produce timely, high-quality work.

• Strong communication and collaboration skills.

• Full-time employees must fulfill a minimum of 30 hours per week to qualify for benefits.

🏝️ Benefits

• Comprehensive medical, dental, and vision healthcare options available from day one.

• Flexible PTO along with unlimited sick time.

• 14 company-paid holidays.

• 401(k) plan through Fidelity with company matching.

• Assistance for adoption and fertility.

• 16 weeks of paid parental leave.

• Company-funded life and disability insurance.

• Remote working environment and wellness reimbursements.

• Employee Assistance Program.

• Opportunities for career development.

• Chances to collaborate with colleagues worldwide.

• Opportunity to research innovative ophthalmic therapies that have a global patient impact.